MAUDE Adverse Event Report: Medico Electrode International LTD Nissha Medical Technologies; ECG Monitoring Electrode

Model Number	A10091-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported skin irritation in the form of itching, rash, and blisters/welts.The patient sought medical treatment and was treated with prescription medication.The patient did not follow proper skin preparation steps.
Additional Manufacturer Narrative
A dhr review was completed with no noted nonconformances or anomalies during production.The materials that are patient contacting are non-cytotoxic, non-sensitizing and non-irritating.Samples were not available for further evaluation.

• Brand Name: Nissha Medical Technologies
• Common Device Name: ECG Monitoring Electrode
• Manufacturer (Section D): Medico Electrode International LTD; plot 142a/11, 12, 27, 28 & 29; economic zone noida, uttar pradesh 20130 5; IN 201305
• MDR Report Key: 50141001
• Report Number: 50141001
• Device Sequence Number: 10731327
• Product Code: DRX
• UDI-Device Identifier: 50009336008341
• UDI-Public: 50009336008341
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2026
• Report Date (Section F): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: A10091-30
• Device Catalogue Number: 32028476
• Device Lot Number: 51325V13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2026
• Event Location: Other
• Date Report to Manufacturer: 08/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/05/2026